© 2019 by MediDev Solutions

Accelerate FDA compliance for Medical Device Hardware and Software Products

MediDev offers software lifecycle, quality & risk management SaaS for digital health software products that fall in the FDA-defined category of “SaMD” or Software as a Medical Device.

MediDev’s SaMD Lifecycle Management Cloud (cloud.medidev.io) is purpose-built for supporting SaMD developers to comply with FDA regulations such as 510(k)/de novo/IDE/PMA requirements for the premarket phase and registration and listing/MDR/Part 806 and QSR procedures for the postmarket phase.

Purpose-built for Medical Device Software approval for FDA

FDA approval process was originally geared towards fixed function medical devices with embedded SiMD (Software in Medical Device). Navigating the FDA approval process for software lifecycle management, risk management and quality management is difficult for software developers who “compose” applications using outsourced microservices, send frequent patches for updates, use smartphone operating systems which stops supporting functionalities in earlier versions and leverage cloud-based deep neural networks which continuously learn from more data.

MediDev’s SaMD Lifecycle Management addresses these challenges.

Preserve your investment in current SW Development Tools

Leverage Medidev Founding Team Experience

MediDev’s founders have 60+ years of experience in ALM (application lifecycle management), PLM (product lifecycle management), IOT, Machine Learning, medical device development, FDA and other regulatory approval process.

MediDev’s purpose-built SaMD cloud supports an Enterprise Service Bus (ESB) with 75+ connectors that allow SaMD developers to connect all the teams to collaborate and continue to use their existing tools for requirement management (e.g. Doors), configuration management (e.g. Perforce, Github/Microsoft), deployment (e.g. Chef), security (e.g. SD elements), defect management (e.g. JIRA) etc.